FDA 510(k) Hematology Devices
FDA 510(k) Hematology Devices - Regulatory Overview
FDA 510(k) hematology devices include automated instruments used to analyze blood composition and coagulation. The FDA review panel code is HE.
Key device categories:
- Complete blood count (CBC) analyzers - automated cell counters for RBC, WBC and platelets
- Coagulation analyzers - PT/INR, aPTT, fibrinogen and factor assays
- Flow cytometry systems - immunophenotyping and cell sorting
- Blood typing and cross-match systems - transfusion medicine instruments
Most hematology devices are classified as Class II under 21 CFR Part 864. Data sourced from FDA 510(k) public files. Updated monthly.
3292
Total
3285
Cleared
161d
Avg (2y)
1976
Since
772 Hematology devices
Cleared
Nov 08, 2022
Sysmex XW-100 Automated Hematology Analyzer
GKZ
Counter, Differential Cell
638d
Cleared
Oct 05, 2022
Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing
GJS
Test, Time, Prothrombin
399d
Cleared
Oct 04, 2022
HemosIL Liquid Anti-Xa
KFF
Assay, Heparin
341d
Not Cleared
Sep 29, 2022
INNOVANCE VWF Ac
QTY
Von Willebrand Factor Assay
701d
Cleared
Sep 14, 2022
FINDER G6PD
JBF
Glucose-6-phosphate Dehydrogenase (erythrocytic), Screening
876d
Cleared
Aug 16, 2022
HemosIL ReadiPlasTin
GJS
Test, Time, Prothrombin
299d
Cleared
Jul 08, 2022
ROTEM sigma Thromboelastometry System
JPA
System, Multipurpose For In Vitro Coagulation Studies
767d
Cleared
Jun 02, 2022
Hemosure Accu-Reader A100
OOX
Automated Occult Blood Analyzer
801d
Cleared
May 09, 2022
Sight OLO
GKZ
Counter, Differential Cell
329d
Cleared
May 03, 2022
X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application
JOY
Device, Automated Cell-locating
119d
Cleared
Apr 19, 2022
V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control
GKA
Abnormal Hemoglobin Quantitation
915d
Cleared
Mar 22, 2022
Athelas Home
GKZ
Counter, Differential Cell
722d
Cleared
Dec 29, 2021
GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 2
JPA
System, Multipurpose For In Vitro Coagulation Studies
518d
Cleared
Jul 02, 2021
iQ200 System, iChemVELOCITY Automated Urine Chemistry System
LKM
Counter, Urine Particle
164d
Cleared
Dec 18, 2020
microINR System
GJS
Test, Time, Prothrombin
231d
Cleared
Nov 06, 2020
cobas u 701 microscopy analyzer
LKM
Counter, Urine Particle
224d
Cleared
Oct 28, 2020
LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer
POV
Semen Analysis Device
92d
Cleared
Oct 23, 2020
Cryocheck Hex LA
GFO
Activated Partial Thromboplastin
305d
Cleared
Oct 16, 2020
CellaVision DC-1, CellaVision DC-1 PPA
JOY
Device, Automated Cell-locating
224d
Cleared
Oct 02, 2020
X100 with Full Field Peripheral Blood Smear (PBS) Application
JOY
Device, Automated Cell-locating
140d
Not Cleared
Sep 17, 2020
HemosIL Liquid Anti-Xa
QLU
Anti-factor Xa Activity Test System, Apixaban
450d
Cleared
Sep 11, 2020
PF4 Enhanced assay
LCO
Platelet Factor 4 Radioimmunoassay
92d
Cleared
Aug 21, 2020
Quantra QPlus System
QFR
Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties
74d
Cleared
Aug 19, 2020
HemosIL von Willebrand Factor Antigen
GGP
Test, Qualitative And Quantitative Factor Deficiency
225d
Cleared
Aug 13, 2020
AncestryDNA Factor V Leiden Genetic Health Risk Test
PTA
Genetic Variant Detection And Health Risk Assessment System
300d
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